Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationCentral MessagePerspective

Background: Even after decades of intensive research, an ideal heart valve prosthesis remains elusive. Shortcomings of conventional devices include reduced durability of bioprostheses and the thrombogenicity of mechanical substitutes, necessitating anticoagulation and resulting in imperfect hemodyna...

Full description

Bibliographic Details
Main Authors: Tim Schaller, MSc, Michael Scharfschwerdt, PhD, Kathrin Schubert, MSc, Cornelia Prinz, PhD, Ulrich Lembke, PhD, Hans-Hinrich Sievers, MD
Format: Article
Language:English
Published: Elsevier 2021-09-01
Series:JTCVS Open
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2666273621001182
_version_ 1798022735963619328
author Tim Schaller, MSc
Michael Scharfschwerdt, PhD
Kathrin Schubert, MSc
Cornelia Prinz, PhD
Ulrich Lembke, PhD
Hans-Hinrich Sievers, MD
author_facet Tim Schaller, MSc
Michael Scharfschwerdt, PhD
Kathrin Schubert, MSc
Cornelia Prinz, PhD
Ulrich Lembke, PhD
Hans-Hinrich Sievers, MD
author_sort Tim Schaller, MSc
collection DOAJ
description Background: Even after decades of intensive research, an ideal heart valve prosthesis remains elusive. Shortcomings of conventional devices include reduced durability of bioprostheses and the thrombogenicity of mechanical substitutes, necessitating anticoagulation and resulting in imperfect hemodynamics. Here we present in vivo results of a novel mechanical heart valve prosthesis aiming for freedom from anticoagulation. Methods: Four female sheep had their aortic valves replaced using the novel mechanical heart valve (size 21 mm), with no postoperative anticoagulation treatment. This trileaflet heart valve was designed with the pivots in the systolic central flow. Hemodynamics, biochemistry, hematology, and macroscopy and microscopy were studied at 90 days in 2 sheep and at 1 year in the other 2 sheep. Results: Mean (<6 mm Hg) and peak (<10 mm Hg) aortic transvalvular gradients remained low during the study period. Aortic regurgitation was trivial, and central traces were only rarely observed. The rate of thrombotic events was very low, with none macroscopically and microscopically visible thrombotic material on the device. Biochemistry and hemotology were unchanged without hemolysis. In 3 sheep, the fibrous pannus and mitral leaflet were partially folded over the edge of the annular body. Apart from organic/inorganic deposits on the leaflets after 1 year, the ultrastructurally evaluated leaflets were similar to those of nonimplanted controls. Conclusions: The preliminary in vivo results of this novel anticoagulation-free aortic mechanical heart valve are promising with excellent hemodynamics and a very low risk of thrombotic events.
first_indexed 2024-04-11T17:34:51Z
format Article
id doaj.art-ba221b8971d1426abe26c40500b0a7c7
institution Directory Open Access Journal
issn 2666-2736
language English
last_indexed 2024-04-11T17:34:51Z
publishDate 2021-09-01
publisher Elsevier
record_format Article
series JTCVS Open
spelling doaj.art-ba221b8971d1426abe26c40500b0a7c72022-12-22T04:11:39ZengElsevierJTCVS Open2666-27362021-09-0177688Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationCentral MessagePerspectiveTim Schaller, MSc0Michael Scharfschwerdt, PhD1Kathrin Schubert, MSc2Cornelia Prinz, PhD3Ulrich Lembke, PhD4Hans-Hinrich Sievers, MD5Department of Cardiac and Thoracic Vascular Surgery, University of Luebeck, Luebeck, Germany; Address for reprints: Tim Schaller, MSc, Department of Cardiac and Thoracic Vascular Surgery, University of Luebeck, Ratzeburger Allee 160, 23538 Luebeck, Germany.Department of Cardiac and Thoracic Vascular Surgery, University of Luebeck, Luebeck, GermanyDepartment of Cardiac and Thoracic Vascular Surgery, University of Luebeck, Luebeck, GermanyDOT GmbH, Rostock, GermanyDOT GmbH, Rostock, GermanyDepartment of Cardiac and Thoracic Vascular Surgery, University of Luebeck, Luebeck, GermanyBackground: Even after decades of intensive research, an ideal heart valve prosthesis remains elusive. Shortcomings of conventional devices include reduced durability of bioprostheses and the thrombogenicity of mechanical substitutes, necessitating anticoagulation and resulting in imperfect hemodynamics. Here we present in vivo results of a novel mechanical heart valve prosthesis aiming for freedom from anticoagulation. Methods: Four female sheep had their aortic valves replaced using the novel mechanical heart valve (size 21 mm), with no postoperative anticoagulation treatment. This trileaflet heart valve was designed with the pivots in the systolic central flow. Hemodynamics, biochemistry, hematology, and macroscopy and microscopy were studied at 90 days in 2 sheep and at 1 year in the other 2 sheep. Results: Mean (<6 mm Hg) and peak (<10 mm Hg) aortic transvalvular gradients remained low during the study period. Aortic regurgitation was trivial, and central traces were only rarely observed. The rate of thrombotic events was very low, with none macroscopically and microscopically visible thrombotic material on the device. Biochemistry and hemotology were unchanged without hemolysis. In 3 sheep, the fibrous pannus and mitral leaflet were partially folded over the edge of the annular body. Apart from organic/inorganic deposits on the leaflets after 1 year, the ultrastructurally evaluated leaflets were similar to those of nonimplanted controls. Conclusions: The preliminary in vivo results of this novel anticoagulation-free aortic mechanical heart valve are promising with excellent hemodynamics and a very low risk of thrombotic events.http://www.sciencedirect.com/science/article/pii/S2666273621001182animal studymechanical heart valveanticoagulationaortic valve replacement
spellingShingle Tim Schaller, MSc
Michael Scharfschwerdt, PhD
Kathrin Schubert, MSc
Cornelia Prinz, PhD
Ulrich Lembke, PhD
Hans-Hinrich Sievers, MD
Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationCentral MessagePerspective
JTCVS Open
animal study
mechanical heart valve
anticoagulation
aortic valve replacement
title Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationCentral MessagePerspective
title_full Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationCentral MessagePerspective
title_fullStr Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationCentral MessagePerspective
title_full_unstemmed Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationCentral MessagePerspective
title_short Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationCentral MessagePerspective
title_sort aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulationcentral messageperspective
topic animal study
mechanical heart valve
anticoagulation
aortic valve replacement
url http://www.sciencedirect.com/science/article/pii/S2666273621001182
work_keys_str_mv AT timschallermsc aorticvalvereplacementinsheepwithanoveltrileafletmechanicalheartvalveprosthesiswithoutanticoagulationcentralmessageperspective
AT michaelscharfschwerdtphd aorticvalvereplacementinsheepwithanoveltrileafletmechanicalheartvalveprosthesiswithoutanticoagulationcentralmessageperspective
AT kathrinschubertmsc aorticvalvereplacementinsheepwithanoveltrileafletmechanicalheartvalveprosthesiswithoutanticoagulationcentralmessageperspective
AT corneliaprinzphd aorticvalvereplacementinsheepwithanoveltrileafletmechanicalheartvalveprosthesiswithoutanticoagulationcentralmessageperspective
AT ulrichlembkephd aorticvalvereplacementinsheepwithanoveltrileafletmechanicalheartvalveprosthesiswithoutanticoagulationcentralmessageperspective
AT hanshinrichsieversmd aorticvalvereplacementinsheepwithanoveltrileafletmechanicalheartvalveprosthesiswithoutanticoagulationcentralmessageperspective